Zilver® PTX® in China

March 21, 2017 updated by: Cook Group Incorporated

Evaluation of the Zilver® PTX® Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery

The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100853
        • Chinese PLA General Hospital
      • Beijing, China, 100029
        • Beijing Anzhen Hospital
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, China, 100029
        • China-Japan Friendship Hospital
      • Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
      • Shanghai, China, 200011
        • Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine
      • Shanghai, China, 200127
        • Renji Hospital Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4
  • Stenotic (>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery
  • Reference vessel diameter of 4-9 mm
  • Lesion length up to 140 mm

Exclusion Criteria:

  • Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure
  • Previous stent in the study vessel
  • Bypass graft with an anastomosis in the study vessel
  • Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion
  • No patent vessel of runoff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zilver® PTX® VI
Device: Zilver® PTX® Drug-Eluting Peripheral Stent
Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary Patency as Assessed by Duplex Ultrasonography
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Study Director: Michael Dake, MD, Stanford University, CA, USA
  • Principal Investigator: Changwei Liu, MD, Peking Union Medical College Hospital, Beijing, China
  • Principal Investigator: Weiguo Fu, MD, Zhongshan Hospital Fudan University, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 9, 2017

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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